Development of a Unified Reversed-Phase HPLC Method for Efficient Determination of EP and USP Process-Related Impurities in Celecoxib Using Analytical Quality by Design Principles

This article presents the development of a reversed-phase (RP) high-performance liquid chromatographic (HPLC) method for determination of process-related impurities in a celecoxib drug substance following Analytical Quality by Design (AQbD) principles. The method from European Pharmacopeia (EP) for...

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Detalles Bibliográficos
Autores principales: Tome, Tim, Časar, Zdenko, Obreza, Aleš
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7070322/
https://www.ncbi.nlm.nih.gov/pubmed/32069880
http://dx.doi.org/10.3390/molecules25040809

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7070322/
https://www.ncbi.nlm.nih.gov/pubmed/32069880
http://dx.doi.org/10.3390/molecules25040809

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